Will sesame join the big eight US allergens?

Posted: 18 March 2021 | | No comments yet

With sesame allergies on the rise in the US, we may see the ingredient added to the list of major allergens which must be declared. Dr Susan Mayne of the FDA explains more…

sesame seeds could soon join the list of allergens monitored by the FDA

There are currently eight major food allergens regulated by the US Food and Drug Administration (FDA). Currently, if a food product contains milk, tree nuts, peanuts, crustacean shellfish, eggs, fish, wheat, or soy, then this must be declared on the packaging in the ingredients section.

Now a new law has just passed through the US Senate which, if cleared by the House and then signed by President Joe Biden, would add sesame to that list. Sesame allergies are becoming increasingly common. In fact, the American Academy of Allergy, Asthma, and Immunology claims it is the ninth most common food allergy in the US.

Dr Susan Mayne, who is Director at the Center for Food Safety and Applied Nutrition at the FDA, was unsure of the reasons behind the rise. “The information available to the FDA indicates that the reported prevalence of sesame allergies in the US population appears to have increased, but we do not have data to gain insights into why this seems to be the case. Other possible explanations could be a growing number of products with sesame seeds or sesame oil and the growing popularity of international foods,” she explained.

Why is correct labelling so important?

Correctly labelling food products is, of course, a basic requirement of most food safety authorities around the world. Yet more than that, it’s essential for consumers with allergens – and the mislabelling of food can, in some cases, be life threatening.

“Undeclared allergens can be a serious problem for food-allergic consumers, depending on how sensitive an individual is to a particular allergen,” added Dr Mayne.

“Every product found to have an undeclared allergen is reviewed on a case-by-case basis. Not declaring a major food allergen is considered a serious potential hazard for the public, so a product that is found to contain an undeclared major food allergen is likely to be subject to recall or other FDA enforcement action. 

“The FDA may also determine that a product containing other potential food allergens not properly listed on the product label could pose a hazard to public health and may recommend enforcement accordingly.”

Whole foods was warned by the FDA over labelling

Whole Foods Market was written to by the FDA over a series of recalls caused by mislabelling

Sending the warning out

The FDA only recently flexed its regulatory muscles to reprimand a producer for not correctly labelling food products, which saw 30 products recalled over the past year.

“FDA analyses patterns in the recalls that are conducted for FDA-regulated products and is aware that many recalls for undeclared allergens were for products sold by Whole Foods Market. To address this recurring problem, we issued a warning letter to the company because of its pattern of receiving and offering for sale misbranded food products,” said Dr Mayne.

“The warning letter to Whole Foods was the first time we have warned a retail establishment for engaging in a pattern of offering for sale misbranded store-brand labelled food products containing undeclared allergens. 

“Whole Foods has responded to the warning letter, and we are evaluating the company’s response and corrective action plans based on what specific steps Whole Foods Market has taken or will take to address the issue of undeclared major food allergens. This includes how Whole Foods Market plans to determine the causes of the undeclared major food allergens and whether Whole Foods Market has implemented corrective actions to prevent undeclared major food allergens from happening again.”

Ultimately, it’s up to food manufacturers to ensure that their products are correctly labelled, though there is plenty of guidance (and requirements) available from agencies like the FDA to inform companies on the best practice.”

Maye added that: “Companies should be aware of applicable FDA allergen requirements, including the FALCPA [Food Allergen Labeling and Consumer Protection Act] labelling requirements and requirements to prevent allergen cross-contact.

“Companies should know that the FALCPA’s labelling requirements extend to retail and food service establishments that package, label and offer products for human consumption.

“Our website has more general information on our strategy to address food allergens.”

A shift towards enforcement

All eyes will no doubt be on Washington DC in the coming weeks to see if the new law regarding sesame is passed by all three legislative bodies in the US.

Former FDA Associate Commissioner for Foods, David Acheson (speaking at Food Integrity), foresees regulatory bodies like the FDA becoming stricter in the near future regardless.

“With a decade having passed since the enactment of Food Safety Modernisation Act (FSMA), the rules are all but rolled out and compliance dates well , so the previous emphasis on education has faded into enforcement, and we are likely to see a great deal more of that when FDA gets back to onsite inspections,” said Acheson. “But even without the onsite inspections, the number of 483 citations for lack of an FSVP issued in 2020 showed a trend toward this intensive enforcement for all things FSMA – domestic or foreign.”

He concluded: “With all this, I would see 2021 as bringing in a distinctly sharper focus on regulation, with a particular emphasis on undeclared allergens and recalls. It’s really nothing new, but it’s definitely something you should be reviewing in and with your facilities.”


 Dr Susan Mayne Dr Mayne came to the FDA in 2015 after spending 27 years at Yale University, where she was the C.-E.A. Winslow Professor and Chair of the Department of Chronic Disease Epidemiology at the Yale School of Public Health, and the Associate Director of the Yale Comprehensive Cancer Center.  

Prior to coming to the FDA, Dr Mayne served two consecutive terms on the Food and Nutrition Board of the National Academy of Sciences, and a five-year term on the Board of Scientific Counselors for the U.S. National Cancer Institute.  

An internationally recognised public health leader and scientist, Dr Mayne received a BA in chemistry from the University of Colorado and a PhD in nutritional sciences from Cornell University. 

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